摘要:

Tioconazole is a new broad-spectrum imidazole antifungal agent with in vitro activity against common yeast pathogens approximately fourfold greater than miconazole. Experimental cream formulations are effective for topical therapy in murine vaginal candidiasis. Systemic exposure to tioconazole following vaginal application is less than that following oral administration. Chronic toxicity studies revealed effects only after oral dosing.

ISSN:1018-8843    

DOI:10.1159/000269562

出版商:S. Karger AG    

年代:1983

数据来源: Karger

ISSN:1018-8843    

DOI:10.1159/000269474

出版商:S. Karger AG    

年代:1983

数据来源: Karger

摘要:

A total of 40 patients took part in two open studies to assess the efficacy, tolerance, systemic absorption and vaginal persistence following a single application of tioconazole 6% ointment (300 mg tioconazole in 5 ml ointment) in the treatment of vaginal candidiasis. At the first review (3–11 days after treatment) 35 of 39 patients (90%) were clinically and mycologically cured. Of these 35 patients cured at first review, 26 were seen at follow-up (26–46 days after treatment); 17 (65%) of this group remained cured. 4 patients reported mild local burning on the day of application. The ointment was administered by the investigator, who found the method of application satisfactory in all patients. Although some leakage of ointment from the vagina was reported by all patients, the amount was considered acceptable. No staining of clothing was reported. Small amounts of tioconazole were detected in the plasma of 9 of the 10 patients. The mean of the peak levels in these 9 patients was 18 ng/ml (range 10–35 ng/ml) and the mode time to attain peak concentrations was 8 h. Tioconazole was detectable in the plasma of only 1 patient 72 h after application. 24 h after a single intravaginal application of tioconazole, the mean concentration of tioconazole in vaginal fluid exudate was 104 mg/l (range 1–23

ISSN:1018-8843    

DOI:10.1159/000269564

出版商:S. Karger AG    

年代:1983

数据来源: Karger

摘要:

The results of studies are described which were designed to assess the efficacy, tolerance, and safety of tioconazole 2% cream administered once daily for 14 days in the treatment of vaginal candidiasis. One study was a double-blind comparison with vehicle cream and the other was an open efficacy study which additionally assessed the systemic absorption of tioconazole in 6 patients. In the double-blind study, 18 patients were treated with tioconazole and 17 with vehicle cream. In the tioconazole group, 12 of 17 patients (71%) were cured (complete clinical and mycologic resolution) at the 7-day review; at the end of treatment, 15 of 16 patients (94%) were cured, and at short-term follow-up (1 week after the end of treatment), 13 of 15 patients (87%) were cured. Of the latter 13 patients, 9 were reviewed at long-term follow-up and all (100%) remained cured. In the vehicle group, 4 of 17 patients (24%) were cured at the 7-day review; at the end of treatment only 3 of 6 patients (50%) were cured. At short-term follow-up, 2 of the 3 patients (67%) cured at the end of treatment remained cured. At long-term follow-up, 1 of the 2 cured at short-term follow-up was reviewed and she remained cured. In all, 13 of the 17 vehicle-treated patients were transferred to tioconazole treatment due to failure of the vehicle. Statistically, tioconazole treatment was significantly more effective than vehicle treatment. In the open part of this study, 11 of 11 patients were cured at the end of treatment. Follow-up reviews were not performed. A total of 6 patients took part in the study in which the systemic absorption of tioconazole was assessed. Bioassay of plasma samples revealed no detectable systemic absorption of tioconazole. No clinically relevant changes in laboratory test results were observed in either study. The creams were found to be generally acceptable in terms of ease of application, leakage from the vagina and staining of clothing.

ISSN:1018-8843    

DOI:10.1159/000269565

出版商:S. Karger AG    

年代:1983

数据来源: Karger

摘要:

A total of 32 patients, 16 in each treatment group, took part in an open study to compare the efficacy, toleration and safety of tioconazole 2% cream and econazole 150-mg ovules administered for 3 days. A total of 14 patients treated with tioconazole and 13 patients treated with econazole were included in the analysis of efficacy. In the tioconazole group, 12 of 13 patients (92%) were cured (complete clinical and mycologic resolution) when seen at short-term follow-up (1 week after starting treatment). Of the 12 patients cured at short-term follow-up, 5 were seen at long-term follow-up and all 5 (100%) remained clinically cured. In the econazole group, 12 of the 13 patients (92%) were cured when seen at short-term follow-up. Of the 12 patients cured, 8 were seen at long-term follow-up and 7 (88%) were clinically cured. No adverse effects were reported in either group. No changes of clinical relevance were observed in laboratory tests. Both treatments were acceptable in terms of application. No leakage from the vagina or staining was reported.

ISSN:1018-8843    

DOI:10.1159/000269566

出版商:S. Karger AG    

年代:1983

数据来源: Karger

摘要:

27 patients, 14 treated with tioconazole vaginal tablets (100 mg) and 13 treated with econazole ovules (150 mg) for 3 days, took part in this open study. 13 of 14 tioconazole-treated patients (93%) were cured (complete clinical and mycologic resolution) at short-term follow-up, compared with 8 of 13 (62%) in the econazole group (p < 0.05). Of those cured at short-term follow-up 8 of 11 (73%) tioconazole- and 3 of 6 (50%) econazole-treated patients remained cured at long-term follow-up. 1 patient in each group reported minor but tolerable, localized burning during treatment. Both drugs were well tolerated and all patients completed the treatment.

ISSN:1018-8843    

DOI:10.1159/000269567

出版商:S. Karger AG    

年代:1983

数据来源: Karger

摘要:

A total of 27 patients took part in an open study to compare the efficacy, toleration and safety of tioconazole 2% cream administered for 3 or 6 days in the treatment of vaginal candidiasis. 13 patients were included in the 3-day and 14 in the 6-day treatment groups. 1 patient dropped out after the initial visit, leaving 13 patients in the former and 13 in the latter group. At short-term follow-up (7 days after the start of treatment) 9 of 13 patients (69%) in the 3-day group were cured (complete clinical and mycologic resolution). Of the 9 patients cured at short-term follow-up, 6 were seen at long-term follow-up and all (100%) were cured. At the end of treatment, 11 of 13 patients (85%) in the 6-day group were cured. Of the 11 patients cured at the end of treatment, 8 were seen at long-term follow-up and all (100%) remained cured. No adverse effects were reported. No abnormalities of clinical relevance were observed in laboratory tests. The cream was acceptable in terms of ease of application and amount of leakage from the vagina. No staining of clothing was reported.

ISSN:1018-8843    

DOI:10.1159/000269568

出版商:S. Karger AG    

年代:1983

数据来源: Karger

ISSN:1018-8843    

DOI:10.1159/000269476

出版商:S. Karger AG    

年代:1983

数据来源: Karger

摘要:

20 women, age 23–49, with culture-confirmed vaginal trichomoniasis were treated on 3 consecutive nights with 5 g of 2% tioconazole vaginal cream, a new imidazole antifungal agent. 4 days following the last administration, 14 patients (70%) had a negative culture for Trichomonas vaginalis. 1 month after entering the study, no relapses were observed and 16 (80%) had negative cultures; only one relapse was noted on long-term (60-day) follow-up. Typical signs and symptoms were severe or moderately severe at baseline in nearly all patients. At 30-day and 60-day follow-up, they were either absent or mild in the patients reporting any symptoms. A burning sensation in 2 patients was the only reported side effect. In separate global evaluations by the physician and the patients, the overall clinical effect was considered satisfactory in all but 1 patient. These results indicate that tioconazole is safe and effective in a short-course treatment of vaginal infection caused by T. vaginalis

ISSN:1018-8843    

DOI:10.1159/000269569

出版商:S. Karger AG    

年代:1983

数据来源: Karger

ISSN:1018-8843    

DOI:10.1159/000269478

出版商:S. Karger AG    

年代:1983

数据来源: Karger